A. What are my responsibilities?

-Ensure XP quality system complying with relevant international standards and relevant

national regulations such as ISO13485, MDD 93/42/EEC, 21 CFR part 820, CMDCAS etc, and

ensure process house implemented in the organization, he/she reports to Quality director of

XP QA.

-Establishment and implementation of quality management system. Integration and

implementation of process house. Assessment and continuous improvement of quality

management system.

-Monitor the status of SSME XP quality targets, monitor the status of CAPAs from CAPA

meeting, internal audit and external audit. Regular reporting on quality target achievement and

QMS performance to  XP QA director.

-Organize the monthly CAPA meeting and improve the CAPA meeting's efficiency.

-Organize the internal audit and support management review in SSME XP.

-Responsible for coordination of external audit in  XP like TUV audit, FDA inspection, etc..

-Working together with each process (from XP and Supporting functions) on

establishment and improvement of processes to fulfill quality system and regulatory

requirements.

-QMS training for XP.

What do I need to qualify for this job?

-Deep understand ISO9001/ISO13485/QSR/MDD

- Good knowledge of relevant standards and regulations of medical device , FDA inspection

experience will be a plus

- With education background of Electronics or Mechanic will be preferred

-Fluent English Speaking

B. What else do I need to know?

The Company Sector is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens offers its customers products and solutions for the entire range of patient care from a single source – from prevention and early detection to diagnosis, and on to treatment and aftercare. By optimizing clinical workflows for the most common diseases.

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